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JZP898 infusion for advanced metastatic solid tumors

A Phase 1, First-in-human, Open-label, Multicenter Study of JZP898 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

PHASE1 · Jazz Pharmaceuticals · NCT06108050

This study is testing a new treatment called JZP898, alone and with another drug, to see if it can help adults with advanced solid tumors feel better and improve their health.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment177 (estimated)
Ages18 Years and up
SexAll
SponsorJazz Pharmaceuticals (industry)
Drugs / interventionsradiation, pembrolizumab
Locations10 sites (Encinitas, California and 9 other locations)
Trial IDNCT06108050 on ClinicalTrials.gov

What this trial studies

This Phase 1 study investigates the safety and effectiveness of JZP898, both as a standalone treatment and in combination with pembrolizumab, for adults with advanced or metastatic solid tumors. The study is divided into two parts: Part A focuses on determining the appropriate dosages and safety profile of JZP898, while Part B evaluates its clinical activity when combined with pembrolizumab. Participants will be closely monitored for pharmacokinetics, immunogenicity, and preliminary antitumor activity.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors who have previously received anticancer therapies.

Not a fit: Patients with solid tumors for whom there are effective standard of care treatments available may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies exploring similar combinations of immunotherapy and targeted treatments have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Adult ≥ 18 years of age
* Histological or cytological diagnosis of advanced or metastatic solid tumor.

  1. Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit.
  2. Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC) who have progressed on/after prior CPI therapy based on investigator assessment per RECIST version 1.1.
* Participants in select tumor types:

  1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
  2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.
  3. Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study.
* ECOG score of 0 to 1.
* Measurable disease per RECIST version 1.1 criteria.
* Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible
* Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions)
* Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;
* Additional criteria may apply

Exclusion Criteria

* Unresolved toxicities from previous therapy that is \> Grade 1.
* Hypersensitivity to mAb, IFNα, or study intervention components.
* Primary CNS tumor or symptomatic CNS metastases.
* Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ).
* Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents.
* Active or history of pneumonitis (noninfectious) or interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Any history of suicidal behavior or any suicidal ideation
* Clinically significant ischemic/hemorrhagic cerebrovascular accident/stroke and/or clinically significant active cardiovascular disease
* Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug
* Received prior radiotherapy within 2 weeks of the first dose of study drug or have had a history of radiation pneumonitis
* Major surgery within 2 weeks prior to the first dose of study intervention.
* Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
* Had a stem cell/solid organ transplant.
* Receipt of prior IFNα therapy

Where this trial is running

Encinitas, California and 9 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor, Metastatic Solid Tumor, JZP898

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.